C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
The overall objective is to evaluate the tolerability/safety and preliminary efficacy of
CINRYZE® (C1 esterase inhibitor [human]) as add-on therapy for treatment of acute optic
neuritis and/or transverse myelitis in NMO and NMOSD.
Primary Objective: To evaluate the safety and tolerability of 3-5 doses of 1000 - 2000 Units
intravenous CINRYZE in NMO/NMOSD patients during an acute exacerbation.
Secondary Objectives:
- To determine the frequency of adverse events with CINRYZE in this patient population.
- To determine the effect of CINRYZE on NMO clinical scores (Expanded Disability Status
Scale and Low Contrast Visual Acuity).
- To compare the change in MRI lesion size and extent following a course of CINRYZE.
Phase:
Phase 1
Details
Lead Sponsor:
Michael Levy
Collaborator:
ViroPharma
Treatments:
Complement C1 Inactivator Proteins Complement C1 Inhibitor Protein Complement C1s